A stability indicating method development and validation of esomeprazole in pharmaceutical dosage form by using RP-HPLC and In Vitro evaluation of nasogastric tube delivery of esomeprazole magnesium delayed-release capsules

Abstract

A simple, selective and well-defined stability indicating method was developed for the quantitative estimation of esomeprazole in tablet dosage form using XBridge BEH Shield RP18 (4.6 x 250 mm), 5μm with phosphate buffer pH 7.3 and acetonitrile (740:260 %v/v) as a mobile phase and successfully validated as per the ICH guideline. The method was found to be specific, linear, accurate, rugged, and robust. Stress degradation studies were performed by exposing the esomeprazole magnesium delayed release capsules into acidic, alkaline, oxidative, thermal, humidity and photolytic stress conditions as per ICH guidelines. In separate in-vitro experiments, esomeprazole pallets dispersion passed through feeding tubes using gentle syringe pressure to develop a clog-free dispersion-delivery method. Nasogastric tube (8-French [Fr]) and diluents (different pH of water used i.e. pH 5.5, 7.0 and 8.5) were tested. The results showed excellent delivery of esomeprazole pellets using water as a medium for tube delivery. Recovery of esomeprazole pallets dispersion in different pH of water i.e. pH 5.5, 7.0 and 8.5 at “0 and 15” minutes incubation time were nearly 100% in 8-Fr nasogastric tubes. Keywords: Esomeprazole, Stress degradation, Stability indicating assay method, Nasogastric Tube.